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U.S. Department of Health and Human Services

Class 2 Device Recall Zweimueller Type Stem SCS

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  Class 2 Device Recall Zweimueller Type Stem SCS see related information
Date Initiated by Firm February 20, 2013
Date Posted May 24, 2013
Recall Status1 Terminated 3 on March 26, 2014
Recall Number Z-1385-2013
Recall Event ID 64588
510(K)Number K110245  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Zweimueller Type Stem SCS-Standard Sz 01
Zweimueller Type Stem SCS-Standard Sz 00
Zweimueller Type Stem SCS-Standard Sz 1
Zweimueller Type Stem SCS-Standard Sz 2
Zweimueller Type Stem SCS-Standard Sz 3
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Zweimueller Type Stem SCS-Standard Sz 5
Zweimueller Type Stem SCS-Standard Sz 6
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Zweimueller Type Stem SCS-Standard Sz 8
Zweimueller Type Stem SCS-Standard Sz 9
Zweimueller Type Stem SCS-Standard Sz 10
Zweimueller Type Stem SCL-Lateralized Sz 3
Zweimueller Type Stem SCL-Lateralized Sz 4
Zweimueller Type Stem SCL-Lateralized Sz 5
Zweimueller Type Stem SCL-Lateralized Sz 6
Zweimueller Type Stem SCL-Lateralized Sz 7
Zweimueller Type Stem SCL-Lateralized Sz 8
Zweimueller Type Stem SCL-Lateralized Sz 9
Zweimueller Type Stem SCR-Revision Sz 3
Zweimueller Type Stem SCR-Revision Sz 4
Zweimueller Type Stem SCR-Revision Sz 5
Zweimueller Type Stem SCR-Revision Sz 6
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Zweimueller Type Stem SCR-Revision Sz 8
Zweimueller Type Stem SCR-Revision Sz 9
Zweimueller Type Stem SCR-Revision Sz 10
Zweimueller Type Stem SCR-Revision Sz 11

Variety of hip and knee implants and instruments, multiple uses.

Code Information Part No. 120.00.15 120.00.00 120.00.01 120.00.02 120.00.03 120.00.04 120.00.05 120.00.06 120.00.07 120.00.08 120.00.09 120.00.10 123.00.03 123.00.04 123.00.05 123.00.06 123.00.07 123.00.08 123.00.09 126.00.03 126.00.04 126.00.05 126.00.06 126.00.07 126.00.08 126.00.09 126.00.10 126.00.11 
Recalling Firm/
Manufacturer		 Orthopedic Alliance LLC
26157 Jefferson Ave
Murrieta CA 92562-9561
For Additional Information Contact
909-304-9001
Manufacturer Reason
for Recall		 The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
FDA Determined
Cause 2		 Labeling design
Action A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in Commerce 50 units
Distribution Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = UNITED ORTHOPEDIC CORPORATION
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